Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT05552235
Eligibility Criteria:
Inclusion Criteria:
* Subject is aged ≥ 18 years old
* Subject has a chronic epicondylitis (\>3 months) OR elbow pain associated with tendonitis OR chronic elbow instability (\>3 months)
* The current condition of his/her elbow allows the subject to continue usual physical activity
* Subject has been informed and is willing to sign an informed consent form
* Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (6 weeks)
* Subject is affiliated to the French social security regime
Exclusion Criteria:
* Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent
* Subject has worn a support (elbow brace or articulated orthosis) in the last month during his/her sport practice
* Subject has any medical condition that could impact the study at investigator's discretion
* Subject has a known hypersensitivity or allergy to the components of the device (polyamide, elastodiene, polyester, elastane)
* Adult subject to legal protection measure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05552235
Study Brief:
Protocol Section:
NCT05552235